Long-term Outcomes Among Patients With Programmed Death-ligand 1 <1% Metastatic Non-small Cell Lung Cancer Treated With First-line Nivolumab + Ipilimumab + 2 Cycles of Chemotherapy

NCT ID: NCT07024862

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-24

Study Completion Date

2025-06-30

Brief Summary

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The study will assess the long-term real-world outcomes among adults diagnosed with programmed death-ligand 1 (PD-L1) \<1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US

Detailed Description

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Conditions

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Metastatic Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1

Adults diagnosed with programmed death-ligand 1 (PD-L1) \<1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US

nivolumab + ipilimumab

Intervention Type BIOLOGICAL

First-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC)

Interventions

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nivolumab + ipilimumab

First-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old at confirmed diagnosis with metastatic non-small cell lung cancer (NSCLC) (stage IV), squamous or non-squamous histology
* Initiated first-line (1L) combination nivolumab, ipilimumab, and 2 cycles of platinum-doublet chemotherapy (NIC) regimen between 01 January 2018 and 2 years prior to study launch
* Tumor programmed death-ligand 1 (PD-L1) negative expression (i.e., PD-L1 \<1%)
* No EGFR, ALK, or ROS1 genetic mutation (i.e., wild type)
* Minimum of 6 months of follow-up after initiation of 1L NIC\*

Exclusion Criteria

• Any prior systemic therapy for metastatic non-small cell lung cancer (NSCLC)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol Myers Squibb Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Cardinal Health

Dublin, Ohio, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA209-1496

Identifier Type: -

Identifier Source: org_study_id

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